EP1621152A1 - Chirurgische Flüssigstrahlvorrichtungen - Google Patents

Chirurgische Flüssigstrahlvorrichtungen Download PDF

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Publication number
EP1621152A1
EP1621152A1 EP05022118A EP05022118A EP1621152A1 EP 1621152 A1 EP1621152 A1 EP 1621152A1 EP 05022118 A EP05022118 A EP 05022118A EP 05022118 A EP05022118 A EP 05022118A EP 1621152 A1 EP1621152 A1 EP 1621152A1
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EP
European Patent Office
Prior art keywords
jet
instrument
lumen
surgical
liquid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP05022118A
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English (en)
French (fr)
Inventor
Timothy E. Moutafis
Kevin Staid
Donald C. Freeman, Jr.
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Hydrocision Inc
Original Assignee
Hydrocision Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hydrocision Inc filed Critical Hydrocision Inc
Publication of EP1621152A1 publication Critical patent/EP1621152A1/de
Withdrawn legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3203—Fluid jet cutting instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3203—Fluid jet cutting instruments
    • A61B17/32037—Fluid jet cutting instruments for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2926—Details of heads or jaws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3203—Fluid jet cutting instruments
    • A61B2017/32032—Fluid jet cutting instruments using cavitation of the fluid

Definitions

  • instruments have been developed and utilized for minimally invasive surgical procedures. Frequently used instruments include blades and scalpel-type instruments, motorized rotary blade instruments, laser instruments, and electrosurgical or electrocautery instruments. Typically, these prior art instruments suffer from a variety of disadvantages. For example, the instruments can be slow and laborious to use, typically they lack the ability to selectively differentiate tissue to be excised from non-target tissue, they tend to have sizes and/or shapes which make access of many surgical sites difficult, and they tend to cause unintended damage to tissue surrounding the intended target tissue.
  • U.S. Patent No. 4,913,698 to Ito et al. describes a liquid jet surgical handpiece designed for crushing and removing brain tumors in cerebral surgery.
  • the disclosed instrument includes a liquid jet forming nozzle and a suction tube, which is required to be coupled to an external source of vacuum for removal of the tissue and debris excised by the liquid cutting jet.
  • the liquid jet nozzle is oriented in such a manner that the liquid jet from the nozzle is directed towards a confronting inside wall of the tip of the suction tube when the instrument is in operation in order to prevent the liquid jet from inadvertently damaging a non-target tissue.
  • U.S. Patent No. 5,135,482 to Neracher discloses a liquid jet instrument for removing a deposit obstructing a vessel in a human body.
  • the device is configured as a multi-lumen catheter, which includes a pressure resistant duct having a nozzle orifice that creates a supersonic cavitating liquid jet.
  • the liquid jet is directed distally from the instrument to ablate a deposit within a vessel.
  • Some embodiments of the catheter device also include a suction lumen which can be coupled to an external source of vacuum for removing liquid and debris from the vessel.
  • the catheter instruments disclosed do not include a deflector or target element to prevent the liquid jet from potentially impinging upon and causing unintended damage to the vessel or tissue surrounding the deposit to be ablated.
  • U.S. Patent No. 5,370,609 to Drasler et al. discloses a fluid jet thrombectomy catheter for removing a thrombus deposit from the cardiovascular system of a patient.
  • the catheter includes a pressure lumen for transporting a high pressure liquid to at least one jet nozzle, and a relatively large bore evacuation lumen for removing liquid and ablated tissue and debris.
  • the catheter is configured to direct at least one liquid jet into the opening of the large-bore evacuation lumen in a direction that is proximal and coaxial with the evacuation lumen. By directing the jet towards the orifice of the large-bore evacuation lumen of the catheter, a stagnation pressure is induced which can propel fluid and debris proximally for removal.
  • U.S. Patent No. 5,527,330 to Tovey discloses a fluid jet cutting and suctioning instrument configured, in some embodiments, for laparoscopic insertion into a patient through a trocar.
  • the instrument includes a body having a handle, an irrigation tube that includes a fluid jet nozzle at its distal end, and an evacuation tube, or in some embodiments a backstop member, positioned to receive the fluid jet.
  • Several of the disclosed embodiments involve an instrument for creating a fluid jet that is directed transversely to a longitudinal axis of the body of the instrument.
  • Yet another device comprises a surgical instrument that has a distal end adapted to perform a surgical procedure on a patient and a proximal end including a body.
  • the instrument includes a pressure lumen that has a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument, and that includes at least one nozzle providing a jet opening.
  • the surgical instrument is constructed and arranged to be entirely disposable after a single use.
  • Another device comprises a surgical instrument that has a distal end adapted to perform a surgical procedure on a patient and a proximal end including a body.
  • the body has a grasping region that is shaped and positionable to be held by the hand of an operator.
  • the instrument includes a pressure lumen having a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument.
  • the pressure lumen includes at least one nozzle providing a jet opening.
  • the instrument further includes an evacuation lumen having a jet-receiving opening locatable opposite the jet opening at a predetermined distance therefrom to receive a liquid jet when the instrument is in operation.
  • At least one nozzle included in the instrument comprises a hole in the side wall of a lumen.
  • the evacuation lumen includes a region that is within and/or downstream of the jet-receiving opening.
  • the evacuation lumen is shaped and positionable so that a liquid within the region is able to macerate at least a portion of a tissue entrained in the liquid into a plurality of particles when the instrument is in operation.
  • Another device comprises a surgical instrument that has a distal end that is adapted to perform a surgical procedure on a patient and a proximal end that includes a body.
  • the body has a grasping region that is shaped and positionable to be held by the hand of an operator.
  • the instrument includes a pressure lumen that has a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument, and that includes at least one nozzle providing a jet opening.
  • the instrument further includes an evacuation lumen that is supported by the body and that includes a jet-receiving opening locatable opposite the jet opening to receive a liquid jet when the instrument is in operation. At least a portion of the pressure lumen and/or evacuation lumen is rotatably moveable relative to the other for adjusting the separation distance between the jet opening and the jet-receiving opening.
  • Yet another device comprises a surgical instrument that has a distal end adapted to perform a surgical procedure on a patient and a proximal end that includes a body.
  • the body has a grasping region that is shaped and positionable to be held by the hand of an operator.
  • the instrument includes a pressure lumen that has a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument, and that has a distal end including at least one nozzle providing a jet opening.
  • the instrument further includes an evacuation lumen supported by the body that includes a jet-receiving opening, which is locatable opposite the jet opening to receive a liquid jet when the instrument is in operation.
  • the distal end of the pressure lumen is shaped to enable the jet opening to be positionable adjacent to a surface to be ablated or debrided such that a liquid jet emanating from the jet opening is separated from the surface by a distance essentially equal to a wall thickness, at the jet opening, of tubing comprising the pressure lumen.
  • Yet another device comprises a surgical instrument that has a distal end that is adapted to perform a surgical procedure on a patient and a proximal end that includes a body.
  • the body includes grasping region that is shaped and positionable to be held by the hand of an operator.
  • the body includes at least two actuating elements, where each of the at least two actuating elements is adapted to be actuatable by a single hand of an operator holding the grasping region.
  • Each actuating element causes an essentially identical predetermined change in a function, shape, position, or orientation of at least a portion of the distal end of the instrument upon actuation of the element.
  • Yet another device comprises a surgical instrument that has a distal end that is adapted to perform a surgical procedure in a patient and a proximal end that includes a body.
  • the body includes a grasping region that is shaped and positionable to be held by the hand of an operator.
  • the body includes at least one actuating element that is adapted to be actuatable by a single hand of an operator holding the grasping region.
  • the evacuation lumen has an internal cross-sectional area which increases essentially continuously from a minimum value at the jet-receiving opening to a maximum value at a predetermined position proximal of the jet-receiving opening. This maximum value is essentially constant at positions proximal to the predetermined position.
  • Another device comprises a surgical instrument that has a distal end that is adapted to perform a surgical procedure on a patient and a proximal end that is adapted to be controllable by an operator.
  • the instrument includes a pressure lumen comprising a tubular conduit having a distal end and a proximal end.
  • the pressure lumen has a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument.
  • the distal end of the tubular conduit has a necked region with a reduced cross-sectional dimension that is less than a cross-sectional dimension of the tubular conduit outside of and proximal to the necked region.
  • the necked region comprises a nozzle that includes a jet opening and is shaped to enable the jet opening to form a liquid jet when a high pressure liquid flows therethrough.
  • the nozzle is oriented so that at least a central region of the liquid jet is directed essentially perpendicular to a longitudinal axis of the conduit outside the necked region.
  • the nozzle is also shaped so that essentially no portion of the jet opening projects radially beyond a perimeter defined by an outer surface of the tubular conduit in a region adjacent to the nozzle but outside the necked region.
  • the invention provides devices specifically for use in a gaseous environment.
  • the invention provides a device for use in a gaseous environment comprising a surgical instrument that has a distal end adapted to perform a surgical procedure on a patient and a proximal end that is adapted to be controllable by an operator.
  • the instrument includes a pressure lumen having a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument, and that includes at least one nozzle providing a jet opening.
  • the instrument further includes an evacuation lumen that has a jet-receiving opening that is locatable opposite the jet opening at a predetermined distance therefrom to receive a liquid jet when the instrument is in operation.
  • Another device for use in a gaseous environment comprises a surgical instrument that has a distal end that is adapted to perform a surgical procedure on a patient and a proximal end that is adapted to be controllable by an operator.
  • the instrument includes a pressure lumen that has a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument, and that includes at least one nozzle providing a jet opening.
  • the instrument further includes an evacuation lumen that has a proximal end and a distal end.
  • the distal end of the evacuation lumen includes a jet-receiving opening that is locatable opposite the jet opening at a predetermined distance therefrom to receive the liquid jet when the instrument is in operation.
  • the evacuation lumen is shaped and positionable to enable evacuation of essentially all of the liquid comprising the liquid jet from the jet-receiving opening to the proximal end of the evacuation lumen without the need for an external source of suction.
  • Yet another device for use in a gaseous environment comprises a surgical instrument that has a distal end that is adapted to perform a surgical procedure on a patient and a proximal end adapted to be controllable by an operator.
  • the instrument includes a pressure lumen that has a sufficient burst strength to conduct a high pressure liquid towards the distal end of the instrument, and that has a distal end including at least two nozzles, where each nozzle provides a jet opening. Each nozzle is shaped to form a liquid jet as a liquid at high pressure flows therethrough.
  • the instrument further includes an evacuation lumen that has a distal end including a jet-receiving opening that is locatable opposite at least one of the jet openings at a predetermined distance therefrom.
  • the predetermined distance between the at least one jet opening and the jet-receiving opening defines a gas-filled gap between the jet opening and the jet-receiving opening.
  • the jet-receiving opening is shaped and positionable to receive at least one liquid jet when the instrument is in operation.
  • the nozzle is shaped to form a liquid jet as a liquid at high pressure flows therethrough, and the liquid jet is directed across a gas-filled gap and into the jet-receiving opening when the instrument is in operation.
  • the nozzle and the jet-receiving opening are shaped and positionable relative to each other so that back-flow of a liquid mist or spray from the jet-receiving opening into the gas-filled gap is essentially eliminated when the instrument is in operation.
  • the liquid jet is directed across a gas-filled gap and into the jet-receiving opening when the instrument is in operation.
  • the nozzle and the jet-receiving opening are shaped and positionable relative to each other so that a cross-sectional shape and area of the liquid jet at a given location within the evacuation lumen is essentially the same as an internal cross-sectional shape and area of the evacuation lumen at the same given location.
  • the given location comprises the jet-receiving opening and/or a location proximal to the jet-receiving opening.
  • the invention provides a method comprising positioning a surgical liquid-jet instrument in close proximity to a surface of a body of patient, creating a liquid jet in a surrounding gaseous environment with the liquid-jet instrument, directing the liquid jet essentially tangential to the surface and towards a jet-receiving opening in an evacuation lumen, debriding a material from the surface with the liquid jet, and evacuating a liquid comprising the liquid jet and the debrided material from the jet-receiving opening to a proximal end of the evacuation lumen without the need for an external source of suction.
  • the invention provides a method for forming a jet nozzle region in a tube.
  • the method comprises necking down an end of a tube providing a lumen to form a jet nozzle region in the tube that has a reduced cross-sectional dimension.
  • the present invention provides a variety of liquid jet instruments useful in a variety of applications, many of which are especially well suited for a variety of surgical procedures.
  • the liquid jet instruments provided by the invention can be configured in a variety of different ways for use in various surgical operating fields.
  • Preferred surgical instruments, according to the invention are configured as surgical handpieces having a proximal end with a grasping region, or handle, shaped and configured to be comfortably held in the hand of an operator.
  • the instruments also have a distal end that includes at least one nozzle for forming a liquid jet. The distal end of the inventive surgical instruments is utilized to perform a surgical procedure on a patient.
  • liquid jet instruments provided by the invention can be used in a wide variety of surgical applications to utilize a high pressure liquid stream to cut, drill, bore, perforate, strip, delaminate, liquefy, ablate, shape, or form various tissues, organs, etc. of the body of a patient.
  • the liquid pressure supplied to the instrument by the pump or dispenser is variably controllable by an operator of the instrument so that the cutting or ablating power of the liquid jet is adjustable by the operator.
  • This adjustability of the pressure can allow an operator to create a liquid jet with the instrument that can differentiate between different types of tissue within a surgical operating field. For example, a lower pressure can be utilized for cutting or ablating a soft tissue such as fat from a surface of a harder tissue, such as muscle or bone, where the liquid jet has sufficient strength to cut or ablate the soft tissue without damaging the underlying harder tissue. A higher pressure can then be selected that is sufficient to form a liquid jet capable of cutting or ablating hard tissue, such as muscle or bone. In this way, a liquid jet surgical instrument provided by the invention can provide highly selective and controllable tissue cutting in various surgical procedures.
  • Preferred embodiments of the inventive surgical instruments also include a liquid jet target or deflector, which is locatable opposite the orifice in the nozzle from which the liquid jet is emitted (hereinafter referred to as the "liquid jet opening” or “jet opening”) at a predetermined distance from the liquid jet opening in order to receive and/or deflect a liquid jet when the instrument is in operation.
  • a target or deflector are preferred because the target/deflector prevents the liquid jet from being misdirected during use and potentially causing damage to unintended tissue sites in the surgical operating field.
  • the target/deflector enables the instrument to provide a predetermined liquid jet length, defined by the predetermined distance between the liquid jet opening in the nozzle and the surface of the target/deflector upon which the liquid jet impinges.
  • the liquid jet can be utilized for performing surgical cutting or ablating of tissue without the danger of causing untended collateral damage to tissue lying beyond the target/deflector in the surgical operating field.
  • the target/deflector can be simply a solid surface capable of deflecting and transforming the liquid jet into a harmless spray.
  • the target is defined by a jet-receiving opening included in an evacuation lumen that forms part of the surgical instrument.
  • the evacuation lumen in addition to providing a defined liquid jet length (defined by the predetermined distance between the liquid jet opening and the jet-receiving opening) and preventing unintended damage to surrounding tissue as discussed above, the evacuation lumen can also be utilized for removing liquid, ablated tissue, and debris from the surgical field with the instrument.
  • an external source of suction for example a vacuum pump or aspirator
  • an external source of suction can be provided in fluid communication with a proximal end of the evacuation lumen in order to provide the suction driving force required for evacuating material from the surgical field via the jet-receiving opening.
  • the invention provides surgical instruments having an evacuation lumen that is shaped and positionable relative to the jet nozzle (as will become apparent to those of ordinary skill in the art from the detailed description below) to enable evacuation of essentially all of the liquid comprising the liquid jet as well as ablated tissue and debris from the surgical site without requiring an external source of suction.
  • the evacuating force created by the liquid jet being directed into the evacuation lumen is sufficient to evacuate material from the operating site to a drainage reservoir located at the proximal end of the evacuation lumen or an evacuation conduit connected to the proximal end of the evacuation lumen.
  • the liquid jet and the evacuation lumen together act as an eductor pump, which utilizes the momentum and kinetic energy of the moving fluid of the liquid jet to create an evacuating force capable of driving the liquid, ablated material, and debris through the evacuation lumen and away from the surgical site.
  • the invention teaches that effective evacuation of material through the evacuation lumen without the use of an external source of suction (i.e., via eductor pump action) requires the design of the inventive instruments to provide certain geometrical relationships between components relating, for example, the size of the jet-receiving opening in the evacuation lumen to the predetermined distance between the jet-receiving opening and the jet opening in the nozzle.
  • the design of the liquid jet nozzle is the design of the liquid jet nozzle, shape of the jet-receiving opening and distal end of the evacuation lumen, the angular orientation of the liquid jet with respect to the evacuation lumen, as well as the surrounding medium in which the surgical instrument is utilized.
  • the present invention provides, in some embodiments, surgical instruments designed to account for some or all of the above-mentioned parameters to provide efficient evacuation, without the need for an external source of suction, for instruments having a wide variety of configurations and intended uses.
  • the invention provides surgical liquid jet instruments constructed and arranged for use in a liquid surgical environment, where the liquid jet opening and the jet-receiving opening are both submerged in a liquid when the instrument is in operation.
  • constructed and arranged for use in a liquid environment refers to an inventive combination of structural features and geometric relationships between such features, which are specifically selected to provide improved performance of the instruments in a liquid environment, as will become readily apparent to those of ordinary skill in the art upon reading the detailed description below.
  • Such devices can be configured as surgical handpieces for use, for example, in endoscopic, arthroscopic, or open surgery. As previously mentioned, such devices could also be configured as catheters for use in the vasculature of a patient.
  • Another class of surgical instruments provided by the invention are constructed and arranged for operation in a gaseous environment, such as in air, where the distal end of the instrument, including the fluid jet nozzle and jet-receiving opening, are essentially completely surrounded by gas when the instruments are in operation.
  • a gaseous environment such as in air
  • the meaning of "constructed and arranged for operation in a gaseous environment” as used herein refers to an inventive combination of structural features and geometric relationships between such features, which are specifically selected to provide improved performance of the instruments in a gaseous environment, as will become readily apparent to those of ordinary skill in the art upon reading the detailed description below.
  • Typical surgical procedures contemplated for using surgical instruments provided by the invention in gaseous environments involve procedures performed in a surrounding air environment, including, for example, surgical procedures on an external surface of a patient or certain open and minimally invasive surgical procedures.
  • the surgical instruments designed for use in a gaseous environment provided by the invention are not limited for use in air but could be used when surrounded by any other gas, for example nitrogen, oxygen, carbon dioxide, mixtures thereof, etc.
  • the surgical liquid jet instruments designed for use in a gaseous environment can be advantageously utilized for a number of surgical procedures including certain open surgeries, laparoscopic surgeries, oral surgeries, and others.
  • One preferred application of the inventive surgical liquid jet instruments for use in an air environment involves the use of such instruments on an external surface of the body of a patient for debriding wounds, bums, sites of infection, and other breaches of the human skin.
  • the term "debriding" when used in this context refers to removal of a material from a surface via the liquid jet instrument.
  • the material removed from the surface can, for example, comprise living tissue, dead tissue, foreign matter or debris embedded in the surface, infective material, etc.
  • preferred geometric relationships and design parameters, for providing efficient operation, for different components of the inventive surgical instruments differ for surgical instruments designed for use when submerged in a liquid and surgical instruments designed for use in a surrounding gaseous environment.
  • the inventive surgical liquid jet instruments in preferred embodiments, can be configured to effectively remove material from a surgical site and transport the material through the evacuation lumen without the need for an external source of suction, for a wide variety of angular orientations between the central region of the liquid jet and the longitudinal axis of the evacuation lumen.
  • the term "central region of the liquid jet” as used herein refers to a region defining the geometric center of the liquid jet. This region is typically an essentially cylindrical region of the liquid jet confined within a cylinder whose outer surface has a shape and perimeter defined by the inner circumference of the liquid jet opening, which circumference is projected from the liquid jet opening to the jet-receiving opening along an axis that is co-linear with the longitudinal axis of the jet nozzle.
  • the "longitudinal axis" of the jet nozzle is defined by the axial center line of the nozzle region of the pressure lumen.
  • the "longitudinal axis" of the evacuation lumen refers to an axis defining the geometric center of the evacuation lumen in a region that is proximal to the jet-receiving opening.
  • the invention provides surgical liquid jet instruments and a surgical method for performing arthroscopic surgical procedures, or other surgical procedures, in joint capsules of a patient, for example in the knee.
  • the invention provides surgical instruments having deployable distal ends.
  • deploymentable refers to a surgical liquid jet instrument having a distal end where either the pressure lumen, the evacuation lumen, or both are moveable relative to each other in order to vary the predetermined distance between the liquid jet opening in the nozzle and the jet-receiving opening in the evacuation lumen.
  • such instruments are inserted into the operating site in an undeployed configuration, where in the undeployed configuration the predetermined distance mentioned above is small or essentially zero and the distal end of the instrument has a minimum cross-sectional dimension for insertion.
  • the operator can, by manipulating the proximal end or body of the instrument, deploy the distal end to provide the desired predetermined distance between the jet opening and the jet-receiving opening and, thus, the desired liquid jet length.
  • the deployment can involve, for example, a longitudinal movement of one or both of the lumen with respect to the proximal end or body of the instrument, a lateral movement of one or both of the lumen, a rotational movement of one or both of the lumen, or a combination of any of the above, so long as the movement involves a change in the predetermined distance between the liquid jet opening and the jet-receiving opening.
  • the proximal end of the instrument comprises a body with a grasping region for an operator.
  • the body can include at least one actuating element that can be manipulated by an operator to cause a pre-determined change in a function, shape, position, or orientation of at least a portion of the distal end of the instrument upon actuation.
  • the actuating element(s) can be used to deploy the distal end of the instrument.
  • the actuating elements preferably cause an essentially identical pre-determined change in a function, shape, position, or orientation of at least a portion of the distal end of the instrument upon actuation, as described in greater detail below.
  • the actuating element(s) can be positioned to be easily actuated by a single hand of an operator for at least two different hand/grasping region orientations, thus permitting the operator to hold the instrument in at least two distinct positions within her hand while still being able to actuate the actuating element(s).
  • the inventive liquid jet surgical instruments advantageously include distal ends that are designed and configured, for some embodiments, to prevent or reduce plugging of the evacuation lumen, blow-by of the liquid jet, or back spray or misting of the liquid jet when the instrument is in operation.
  • "Blow-by" of the liquid jet refers to a portion of the liquid jet, or a high velocity fluid entrained by the liquid jet (comprising the "entrainment region” as discussed below), having a cross-sectional area, at the plane of the jet-receiving opening, that is larger than the cross-sectional area of the jet-receiving opening so that at least a portion of the liquid jet or high velocity fluid misses or "blows by" the jet-receiving opening.
  • Back spray refers to a liquid jet, or high velocity fluid entrained by the liquid jet, entering the jet-receiving opening in the evacuation lumen and subsequently reflecting or flowing back into the surgical field from the jet-receiving opening.
  • back spray is undesirable in operation due to the potential of contamination of the surgical operating field and/or aerosolization of infective material, in addition, back spray typically indicates a poor efficiency level of the evacuation of material by the instrument via eductor pump action.
  • the surgical instruments provided by the invention substantially reduce, and in preferred embodiments essentially eliminate, performance problems associated with blow-by and back spray when the instruments are in operation.
  • Plugging of the evacuation lumen can be prevented, for embodiments involving surgical instruments designed for operation in a liquid environment, by constructing the evacuation lumen to have a region that is within and/or downstream of the jet-receiving opening that is designed to be able to macerate at least a portion of the tissue entrained by the liquid jet into a plurality of particles when the instrument is in operation.
  • the term "macerate” as used herein refers to a disaggregation of entrained material, for example an entrained tissue, by a liquid within the evacuation lumen undergoing intensely turbulent flow that creates a region of extremely high fluid shear and impacting forces capable of partitioning the material into particles having a size small enough to pass through the evacuation lumen without plugging the lumen.
  • the evacuation lumen is able to macerate a substantial fraction of the tissue entrained into a plurality of essentially microscopic particles.
  • "Microscopic" as used herein refers to particles having a dimension too small to be visualized unaided by the human eye.
  • Prevention of blow-by and back spray can be accomplished by providing a surgical liquid jet instrument having a distal end configured so that when in operation, the liquid jet and the high velocity fluid entrained by the liquid jet occupies a substantial fraction of the cross-sectional area of the jet-receiving opening, but does not occupy a region larger than the cross-sectional area of the jet-receiving opening.
  • this "substantial fraction” refers to at least 50%, but less than 100% of the cross-sectional area of the jet-receiving opening being occupied by an entrainment region created by the liquid jet.
  • Fig. 1 shows one embodiment of a liquid jet surgical system 100 utilizing a liquid jet surgical instrument 102, according to the invention.
  • the surgical instrument 102 illustrated is configured as a surgical handpiece having a proximal end 103 including a body 104 having a grasping region 106 configured for placement in the hand of an operator of the instrument.
  • the surgical instrument 102 has a distal end 108 including a pressure lumen 110 and an evacuation lumen 112.
  • "Distal end" when used herein in the context of a region of a surgical instrument refers to the portion of the surgical instrument that is adapted to perform a surgical procedure on a patient, and which is inserted into a surgical site during operation of the instrument.
  • the distal end of the instrument 108 can, in some embodiments, comprise only the distal ends of pressure lumen 110 and evacuation lumen 112, or in other embodiments, can include components proximal to the distal ends of the pressure lumen 110 and the evacuation lumen 112 that are also inserted into a surgical operating space of the patient during use of the instrument.
  • surgical instrument 102 further includes a sheath 114, which at least partially surrounds pressure lumen 110 and evacuation lumen 112 and supplies support for the lumen to assists in maintaining and/or establishing a desired geometric configuration between pressure lumen 110 and evacuation lumen 112, when the instrument 102 is in operation.
  • Pressure lumen 110 further includes at its distal end a nozzle 116, which forms a liquid jet as a high pressure liquid supplied by pressure lumen 110 streams therethrough.
  • Evacuation lumen 112 includes a jet-receiving opening 118 located at its distal end and positioned, when the instrument 102 is in operation, opposite the jet nozzle 116 at a predetermined distance therefrom in order to receive the liquid jet 120.
  • liquid jet 120 is directed transversely (e.g., at an angle of approximately 90°) with respect to the longitudinal axes of the evacuation lumen 112 and the body 104 of the instrument 102.
  • the evacuation lumen 112 preferably includes a jet-deflecting portion 122 downstream and adjacent to the jet-receiving opening 118 that is utilized to deflect and direct the liquid entering the jet-receiving opening 118 proximally within evacuation lumen 112.
  • Pressure lumen 110 and evacuation lumen 112 are preferably constructed from a surgical grade stainless steel, however, in alternative embodiments, either or both of the lumen may be constructed from other suitable materials, for example certain polymeric materials, as apparent to those of ordinary skill in the art. Regardless of the specific material from which the pressure lumen is constructed, pressure lumen 110 must have sufficient burst strength to enable it to conduct a high pressure liquid to nozzle 116 in order to form liquid jet 120. The burst strength of pressure lumen 110 should be selected to meet and preferably exceed the highest contemplated pressure of the liquid supplied for use in the specific surgical procedure to be performed. Typically, surgical instrument 102 will operate at liquid pressure between about 500 psig and about 50,000 psig, depending on the intended material to be cut and/or ablated. Those of ordinary skill in the art will readily be able to select appropriate materials for forming pressure lumen 110 and evacuation lumen 112 for particular surgical requirements.
  • high pressure liquid supply conduit 126 comprises a burst-resistant stainless steel hypotube constructed to withstand at least 50,000 psig.
  • the hypotube may be helically coiled to improve the flexibility and maneuverability of the surgical instrument 102.
  • high pressure liquid supply conduit 126 comprises a Kevlar reinforced nylon tube that is connectable to the pressure lumen 110.
  • high pressure pump 124 In fluid communication with high pressure liquid supply conduit 126 is a high pressure pump 124, which can be any suitable pump capable of supplying the liquid pressures required for performing the desired surgical procedure. Those of ordinary skill in the art will readily appreciate that many types of high pressure pumps may be utilized for the present purpose, including, but not limited to, piston pumps and diaphragm pumps.
  • high pressure pump 124 comprises a disposable piston or diaphragm pump, which is coupled to a reusable pump drive console 128.
  • High pressure pump 124 has an inlet that is in fluid communication with a low pressure liquid supply line 130, which receives liquid from liquid supply reservoir 132.
  • Pump drive console 128 preferably includes an electric motor that can be utilized to provide a driving force to high pressure pump 124 for supplying a high pressure liquid in liquid supply conduit 126.
  • the preferred pump drive console includes a constant speed electric motor that can be turned on and off by means of an operator-controlled switch 134.
  • operator-controlled switch 134 comprises a foot pedal or a button or trigger located on grasping region 106 of the surgical instrument 102 that may be easily accessed by the operator of the instrument.
  • pump drive console 128 can have a delivery pressure/flow rate that is factory preset and not adjustable in use. In other embodiments, the pressure/flow rate may be controlled by the operator via an adjustable pressure/flow rate control component 136, that can control the motor speed of the pump drive console and/or the displacement of the high pressure pump. While in Fig.
  • pressure/flow rate control component 136 is illustrated as a knob on pump drive console 128, in preferred embodiments, such component would preferably comprise a foot pedal, or trigger/button located on grasping region 106, as previously discussed for on/off control of the pump drive console 128.
  • pump drive console 128 and high pressure pump 124 may be replaced by a high pressure liquid dispenser or other means to deliver a high pressure liquid, as apparent to those of ordinary skill in the art.
  • the liquid utilized for forming the liquid cutting jet can be any fluid that can be maintained in a liquid state at the pressures and temperatures contemplated for performing the surgical procedures.
  • the liquid utilized should also be physiologically compatible.
  • the liquid supplied will be a sterile surgical saline solution, or sterile water and liquid supply reservoir 132 can comprise a sterile container, such as an intravenous (IV) bag containing such fluid.
  • IV intravenous
  • the liquid in order to improve the cutting or ablating character of the liquid jet, may contain solid abrasives, or the liquid may comprise a liquefied gas, for example carbon dioxide, which forms solid particulate material upon being admitted from nozzle 116 to for the liquid jet 120.
  • the liquid supplied to surgical instrument 102 may include medicaments, such as antiseptics, antibiotics, antiviral components, anesthetics, drugs, chemotherapy agents, etc., that are useful in the context of a specific surgical procedure.
  • the fluid may include a dye to improve visualization of the liquid jet when the instrument is in operation.
  • Evacuation lumen 112 is connectable at its proximal end to an evacuation conduit 138, which can be used to transport evacuated material and debris to a drainage reservoir 140.
  • the liquid contained in evacuation conduit 138 is under relatively low pressure and, accordingly, evacuation conduit 138 may be constructed, in preferred embodiments, of a low cost flexible material, for example, polymeric tubing, such as polyvinyl chloride (PVC), silicone, polyethylene, rubber, etc. tubing.
  • evacuation conduit 138 should have a minimum internal cross-sectional area that equals or exceeds the maximum internal cross-sectional area of evacuation lumen 112.
  • surgical instrument 102 is constructed such that evacuation lumen 112 is capable of evacuating liquid jet 120 and ablated material and debris from the jet-receiving opening 118 to the proximal end of evacuation lumen 112 and through evacuation conduit 138 into drainage reservoir 140, without the need for an external source of suction.
  • evacuation conduit 138 include a vacuum breaker 142 or a proximal end that is not couplable to an external source of suction, so that it is not possible for an operator to inadvertently couple evacuation conduit 138 to an external source of suction when the instrument is in operation.
  • the fluid supply path of liquid jet surgical system 100 is disposable, and sterilizable, for example by chemical methods such as exposure to ethylene oxide, or by gamma or beta irradiation, as apparent to those of ordinary skill in the art.
  • the fluid path is supplied pre-sterilized to the user for a single use only.
  • liquid jet surgical system 100 are entirely disposable after a single use except for pump drive console 128.
  • the surgical liquid jet instrument is disposable after a single use, the instrument is preferably sterilizable, and most preferably provided pre-sterilized. In other embodiments, only the pressure lumen and the distal end of the instrument for insertion into the patient are sterilizable or pre-sterilized.
  • Grasping region 106 may be configured in a wide variety of shapes and configurations depending on the ergodynamics of a particular surgical operating procedure and/or the preference of a particular operator.
  • the grasping region 106 illustrated which comprises an elongated handle
  • the grasping region may be formed in the shape of a pistol, or with loops, straps, rings, finger slots, etc., as apparent to those of ordinary skill in the art.
  • Surgical instrument 102 is shown in greater detail in Fig. 2a.
  • Fig. 2a shows partially cutaway views of body 104 of surgical instrument 102, sheath 114, pressure lumen 110 and evacuation lumen 112.
  • jet opening 144 located at the outlet of nozzle 116, which jet opening 144 defines the apex of liquid jet 120 as it is emitted from nozzle 116.
  • liquid jet 120 is directed into jet-receiving opening 118 such that the axis 146 defining the direction of the central region of liquid jet 120 is essentially perpendicular to the longitudinal axis of sheath 114 and the proximal end 103 of surgical instrument 102.
  • Sheath 114 can comprise a tube that is attached at its proximal end to the body 104 of surgical instrument 102 and which includes two channels therewithin. Through one channel 115 traverses pressure lumen 110 and through the other channel 117 traverses evacuation lumen 112. The channels 115, 117 through which the lumen 110, 112 traverse are separated by a central spacer region 148. Sheath 114 may be constructed from a variety of known materials, as apparent to those of ordinary skill in the art. In preferred embodiments, sheath 114 is constructed of a surgical grade stainless steel.
  • sheath 114 may comprise a simple tube without central region 148, and the pressure lumen and evacuation lumen may be disposed within the sheath, such that they are in direct contact with each other along the length of the sheath. Such an embodiment is preferred for devices where a minimal cross-sectional dimension of the distal end of the instrument is desirable.
  • Pressure lumen 110 and/or evacuation lumen 112 may be rigidly connected to the sheath 114 in one or more locations along the length of the sheath, for embodiments where the lumen are immobile with respect to the sheath.
  • at least one of the lumen may be slidable and/or rotatable within the sheath.
  • the lumen may be immobilized within sheath 114 via a variety of methods, for example, by simple friction between the walls of the lumen and the inner surface of one or more portions of sheath 114, by welding, gluing, press fitting, or other methods of affixing an outer surface of a lumen to an inner surface of the sheath, or by any other methods apparent to those of ordinary skill in the art.
  • sheath 114 may be eliminated entirely.
  • the pressure lumen and evacuation lumen may be directly connected to each other, for example, by welding, gluing, etc., or may be coupled to each other via straps, rings, clips, or other means apparent to those of ordinary skill in the art.
  • the high pressure tubing coupler can be secured to the ends of the pressure lumen and the high pressure liquid supply conduit by means of an epoxy adhesive or other sealant as apparent to those of ordinary skill in the art.
  • the high pressure tubing coupler may comprise a high pressure detachable or uncouplable element, such as a variety of high pressure tubing fittings known to those of ordinary skill in the art.
  • the proximal end 154 of evacuation lumen 112 can be coupled to evacuation conduit 138 via a low pressure tubing coupler 156.
  • the desired size of jet-receiving opening 296 is typically determined experimentally, for example by creating a liquid jet in a gaseous environment using a desired liquid supply pressure and a given nozzle configuration, visually observing the diverging liquid jet formed, and estimating angle ⁇ from the observation. The appropriate jet-receiving opening size can then be selected based on ⁇ and the desired separation distance l.
  • evacuation lumen 282 it is also desirable to shape and position evacuation lumen 282 with respect to jet opening 290 so that the cross-sectional shape and area of liquid jet 288 at a given location 298 within evacuation lumen 282 is essentially the same as the internal cross-sectional shape and area of evacuation lumen 282 at given location 298.
  • Given location 298 may coincide with jet-receiving opening 296 or may be located proximal to jet-receiving opening 296.
  • given location 298 is located proximal to jet-receiving opening 296, preferably the given location 298 is no greater than about 5 mm proximal to jet-receiving opening 296.
  • surgical instrument 470 includes a body 472 having a grasping region 474 configured to be held within the hand of an operator and an actuating element 476 that comprises a slidable sleeve or collar, which is used to deploy the distal end 478 of surgical instrument 470.
  • Slidable sleeve 476 is positioned to be easily actuated by a single hand of an operator of instrument 470.
  • the operator can grip body 472, for example, with her thumb positioned toward the proximal end of body 472, while actuating slidable sleeve 476 via one or more of the other four fingers of her hand.
  • At least one cross-sectional dimension of distal end 478 when in the undeployed configuration, should be no greater than about 2.8 mm, the length of distal end 478 is preferably between 10 and 15 mm, and angle ⁇ is preferably about 15 degrees.
  • Pressure lumen 488 is fixably mounted within body 472, so that it is essentially immobile with respect to body 472, and is rotatably mounted within sheath 482 and rotatably mounted component 480 so that the sheath can rotate around the outer surface of the pressure lumen upon deployment of distal end 478.
  • axis 504 which defines the direction of a central region of the liquid jet emitted from jet opening 498 when the instrument is in operation, is non-parallel with respect to the longitudinal axes of sheath 482 and body 472 of instrument 470.
  • axis 504 forms an angle with respect to the longitudinal axis of body 472 that is between about 45 and 115 degrees, more typically between about 80 and about 100 degrees, and most typically about 90 degrees.
  • Aperture 514 is located on the distal surface of actuating element 476 and has a circumference that is nearly equal or slightly greater than the outer circumference of rotatably mounted component 480, thus allowing rotatably mounted component 480 to pass through, and rotate within, aperture 514.
  • Bearing flange 496 of rotatably mounted component 480 is rotatably mounted within bearing slots 516 of body 472.
  • actuating element 476 includes a pin 518 mounted within aperture 514. As shown more clearly in Fig.
  • Figs. 12a-12e show an alternative embodiment for a rotatably deployable surgical liquid jet instrument according to the invention.
  • surgical instrument 530 is shown, which has a body 532 including an outer body component 534 with an external surface 536 that acts as a grasping region, and an internal body component 538, which is slidably mounted within outer body component 534.
  • Inner body component 538 includes two actuating elements 540, 542, each of which may be actuated by the hand of an operator holding grasping region 536. By sliding either actuating element in the direction indicated by arrows 544 and 546, the operator can create a rotational movement of rotatably mounted component 548 and sheath 550 in the direction indicated by arrow 552.
  • rotatably mounted component 548 includes bearing flange 554 at its proximal end. Bearing flange 554 is rotatably mounted within bearing slots 556, which are connected to outer body component 534 as shown more clearly in Fig. 12d. Rotatably mounted component 548 extends distally from bearing slots 556 through aperture 558 in actuating element 540.
  • Actuating element 540 includes a pin 560 which traverses slot 562 in rotatably mounted component 548 when instrument 530 is assembled (similar to the configuration shown previously in Fig. 11e).
  • outer body component 534 and inner body component 538 comprise components that are injection molded from a lightweight, inexpensive, and durable polymeric material.
  • the components may be manufactured as two symmetrical halves (e.g., halves 582 and 584 of outer body component 534), which may be connected together upon assembly of instrument 530. Connection points between the halves of the components, shown as 578 and 580, can be snap-fit joints, or may be connected together via screws, clips, clamps, tape, adhesives, solvent fusing, or any other suitable means of attachment as apparent to those of ordinary skill in the art.
  • tubing support component 628 on outer body component half 608 can interact with a complementary component on outer body component half 610 to support and immobilize the pressure and evacuation lumen/conduits, when instrument 600 is assembled.
  • sheath support components 630 on inner body component halves 616 and 618, and sheath support components 632 on outer body component halves 608 and 610 act to support and properly position rotatably mounted component 602 when instrument 600 is assembled.
  • the component halves of the inner and outer body components are further secured together by gluing, solvent bonding, ultrasonic welding, or press fitting, but may, in other embodiments, be secured by a variety of means apparent to those of ordinary skill in the art including, but not limited to, screws, clips, clamps, straps, etc.
  • the deployable surgical instruments described above are especially useful for performing surgical procedures in confined regions internally of a body defining a confined surgical operating space.
  • the distal ends of the instruments are provided with a contour in size that is specifically selected to facilitate inserting the distal end of the surgical instruments into the confined regions, when the instrument is in an undeployed configuration.
  • the inventive instruments enable the performance of novel surgical methods utilizing the inventive instruments.
  • the deployable surgical liquid jet instruments described above may be advantageously employed for use in a surgical method involving the cutting or ablating of a selected tissue within the joint capsule of a patient.
  • the method comprises inserting a surgical-liquid jet instrument, provided by the invention, and having a distal end specifically designed for the surgical procedure, into the joint capsule of the patient.
  • a representative procedure, meniscectomy of a human knee, employing the inventive fluid jet cutting system is described immediately below.
  • the patient to be operated on is anesthetized and a tourniquet is applied the thigh of the leg and set to a pressure of about 280 mm Hg.
  • the patient is then prepped and draped in the conventional manner.
  • Saline is introduced into the knee either through a superior medial portal, using an inflow canula, or through a scope canula placed in the lateral portal at the joint line. Saline can exit the knee cavity out of the medial portal at the joint line.
  • the pathology of the knee can be visualized through use of an endoscopic camera.

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  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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EP05022118A 1999-05-18 2000-05-18 Chirurgische Flüssigstrahlvorrichtungen Withdrawn EP1621152A1 (de)

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US09/313,679 US6375635B1 (en) 1999-05-18 1999-05-18 Fluid jet surgical instruments
EP00932590A EP1182974B1 (de) 1999-05-18 2000-05-18 Chirurgische flüssigstrahlvorrichtungen

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CA2373687C (en) 2007-10-30
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US8062246B2 (en) 2011-11-22
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DE60023136D1 (de) 2005-11-17
EP1182974A1 (de) 2002-03-06
US6960182B2 (en) 2005-11-01
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